ECHELON FLEX PSEE45A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for ECHELON FLEX PSEE45A manufactured by Ethicon Endo-surgery, Llc.

MAUDE Entry Details

Report Number9391772
MDR Report Key9391772
Date Received2019-11-29
Date of Report2019-11-20
Date of Event2019-09-05
Report Date2019-11-20
Date Reported to FDA2019-11-20
Date Reported to Mfgr2019-11-29
Date Added to Maude2019-11-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameECHELON FLEX
Generic NameSTAPLE, IMPLANTABLE
Product CodeGDW
Date Received2019-11-29
Model NumberPSEE45A
Catalog NumberPSEE45A
Lot NumberT93E8T
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerETHICON ENDO-SURGERY, LLC
Manufacturer Address475 CALLE C GUAYNABO PR 00969 US 00969


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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